DEPUY CMW 1G 40G

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

Description of Event or Problem

THE FINAL COMPONENTS AND THE CEMENT DOSAGE ARE TRANSFERRED, AND PREPARATION BEGINS IN FRONT OF THE DOCTOR. UPON STARTING TO MIX, IT IS OBSERVED THAT THE CEMENT HAS A MORE "SANDY" TEXTURE THAN USUAL, SO THE DOCTOR DOES NOT ALLOW THIS CEMENT TO BE PLACED AND REQUESTS ANOTHER UNIT. THE SURGICAL TEAM IS ALSO IMMEDIATELY NOTIFIED, AND THEY TOO CONFIRM THE LACK OF CONSISTENCY IN THE CEMENT.